NEWS AND DEVELOPMENT
- Elios Therapeutics, LLC recently received FDA approval of its Investigational New Drug (IND) application and its randomized phase IIb trial planned to enroll 120 stage III and IV (resected) melanoma patients to assess the ability of a personalized vaccine to prevent recurrence.
- Vaccine for Cancer Comes Closer to Fruition as Immunotherapy Pioneer Joins Orbis Health Solutions
- Buddy Long, president of Perseus PCI, the advanced cancer treatment center headquartered in the Cayman Islands, has announced the appointment of Dr. Sook Yin MD as treating physician and clinic director at the company’s Cayman Islands clinic.
- A US-based doctor and biomedical researcher who has developed a radiation and chemotherapy-free cancer treatment has opened a clinic in the Cayman Islands because, he says, the wait for the Food and Drug Administration's approval is years away.
- Clinical trials of a cancer vaccine for patients with a specific stage of melanoma have begun at Perseus, a Cayman company that specializes in personalized cancer immunotherapeutics (PCI) that treat solid tumors.
Cancer vaccine clinical trials begin for patients in Cayman
Clinical trials of a cancer vaccine for patients with a specific stage of melanoma have begun at Perseus, a Cayman company that specializes in personalized cancer immunotherapeutics (PCI) that treat solid tumors.
Under the direction of cancer vaccine pioneer Dr. George Peoples, the newly named chief medical officer of Orbis/Perseus, patients will be brought to Cayman for a series of injections that will be tailored to stimulate their immune system to recognize and destroy their specific tumor.
Dr. Peoples, who has helped to invent various other cancer vaccines while serving as the director of the Cancer Vaccine Development Program and deputy director of the U.S. Military Cancer Institute, was in Cayman this month along with Perseus president Buddy Long. He explained the significance of these new trials for cancer sufferers.
“Orbis, the parent company of Perseus in the United States, has undertaken 12 years of clinical research and trials under the approval and guidance of the Food and Drug Administration, part of an ongoing FDA process of approval to have our cancer vaccines available in the United States.
“This is a long and extremely costly process that involves various stages before the vaccine can receive FDA approval. Our cancer vaccine has passed the laboratory and animal stages and the first stage in patients, which is to prove that it is safe, and now we need to begin the second stage, to prove that the vaccine actually works,” he explained.
Cayman the right fit
Dr. Peoples and Mr. Long said they looked to other jurisdictions close to the United States that would provide them with a base to continue their clinical trials.
“As a mark of validation of our work, we were looking at jurisdictions with a strong regulatory environment because we want our data to be scrutinized,” Long said. “Cayman was the ideal location. We picked our location at the Smith Road Centre and had commenced construction of the lab and treatment facility even before we had the approval to begin our research by the local authorities; we were that committed to the program. Our studies all follow FDA guidelines and have full approval of the Health Practice Commission.”
In the United States, Perseus has treated 25 patients with stage IV melanoma (skin cancer) which had spread to other organs in the body. On average, these patients had been given eight months or less to live.
“After receiving the vaccine, these patients lived on average 14-1/2 months, and 27 percent were completely cured and alive greater than five years later. These statistics were enough to get people’s attention,” Dr. Peoples said.
“But we need a bigger trial to get the FDA approval required. In addition, technology has changed in recent years, and we need to incorporate that into our new trials.”
Perseus has been in operation in the Cayman Islands for almost a year and has already treated eight cancer patients who were diagnosed with stage IV cancer. The vaccine technology has again proven to be safe, and so far, appears to be more effective than their previous vaccines.
“We have a dozen or so melanoma patients identified who will come to Cayman over the next few weeks for treatment,” Dr. Peoples added. “We have already proven that the treatment is safe, now we have to prove that it’s effective to get to phase III of the FDA approval process, which is to undergo far more extensive clinical trials. We have some of the most important melanoma treatment centers in America set to go on our pivotal trial as soon as we collect more information on the patients being treated here in the Cayman Islands.”
How the treatment works
The PCI vaccine undertaken by Perseus follows the work of American cancer researcher Dr. Thomas Wagner, who created the Perseus technology. It involves taking small samples of the patient’s tumor, which are then used to make a vaccine that’s tailor-made to the individual patient. The tumor cells are then introduced into the body’s dendritic cells (responsible for fighting infection), which then stimulate a strong immune response to kill the patient’s cancer cells.
Patients brought to Cayman for the procedure, which involves a series of four injections over four months, will have their stay completely coordinated by Perseus, under the guidance of Dr. Sook Yin. Because the trial process will benefit from the data generated by melanoma patients treated over the next few months, Perseus is subsidizing the cost for 20 melanoma patients. The cost of treatment is US$50,000, but 2014 subsidies available from Perseus include US$40,000 subsidy for 20 patients with any stage melanoma, while all solid tumor disease cases (other than melanoma) can receive a subsidy of up to US$25,000. The cost covers treatment, flights and accommodation while in the Cayman Islands. Caymanian patients are eligible for an additional US$5,000 in subsidy for any solid tumor disease, any stage.
In addition, Perseus will offer their treatment to other patients suffering from a wide variety of cancers, such as those of the breast, colon and lung.
Dr. Peoples said that around 10 to 20 patients are needed to complete the information required to launch the large U.S. trial, and he hopes that the trial will be initiated later this year.
Available in Cayman
Perseus now wants to make its cancer treatments available to Cayman residents.
“We want Caymanians to have access to our technology, and we want to provide vaccines to cancer patients in Cayman,” said Dr. Peoples. “In addition to being involved in our trials, we have also discussed with the local medical community and government officials, the possibility of making our novel cancer vaccine therapies available to any and all cancer patients in Cayman.”
“The exact details are still being worked out,” he said.
Source: Cayman Compass